Active Ingredient
Phenol 1.4%
Signature Care Spray
FDA Label NDC 21130-196
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Signature Care (NDC 21130-196). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product,, stop use and ask a dentist or doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral pain reliever
Uses
for the temporarily relief of occasional minor irritation, pain, sore mouth, and sore throat.
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by a doctor.
When Using This Product,
do not exceed recommended dosage.
Stop Use And Ask A Dentist Or Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
If Pregnant Or Breast-Feeding,
ask a heath professional before use.
Keep Out Of Reach Of Children.
If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222
Directions
- Adults and children 12 years of age and older: Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out
- Use every 2 hours as directed by a doctor or dentist
- Children 6 years to under 12 years of age: should be supervised in the use of this product
- Children under 6 years, Consult a doctor or dentist
Other Information
- Store at room temperature.
- Check expiration date before using.
Inactive Ingredients
FD&C Red #40, glycerin, flavor, purified water, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Signature SELECT™
COMPARE TO the active ingredient in Chloraseptic®*
NDC# 21130-196-06
SORE THROAT SPRAY
CHERRY FLAVOR
Phenol 1.4%
Oral Pain Reliever
- Fast Acting
- Numbs on Contact
SUGAR-FREE
ASPIRIN-FREE
6 FL. OZ. (177 mL)
Tamper-Evident: Do not use if imprinted shrink band is broken or missing
Distributed by: BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929
*This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®.
* Please review the disclaimer below.
